Legal and regulatory issues in eHealth

Legal and regulatory issues in eHealth

Luxembourg, 2nd December 2005Luxembourg, 2nd December 2005Luxembourg, 2nd December 2005

Dr Octavian PurcareaDr Octavian PurcareaUnit H1 Unit H1 –– ICT for HealthICT for Health

Directorate ICT for citizens and Directorate ICT for citizens and businessesbusinessesDG INFSODG INFSO

EU CommissionEU Commission

OverviewOverview

••ContextContext

••Legal textsLegal texts

••Future developmentsFuture developments

••ActionsActions

••Discussion Discussion

The current situationThe current situation

Integration of data; long term Integration of data; long term availability of knowledge; grid availability of knowledge; grid technologytechnology

Multidisciplinary Decision Multidisciplinary Decision Support systems, Support systems, epidemiology, clinical researchepidemiology, clinical research

Shared information; Shared information; interoperability of EHR; interoperability of EHR; legal legal framework in placeframework in place

Mobility of patients across Mobility of patients across bordersborders

Research, implementation Research, implementation economically viableeconomically viable

Implementation costImplementation cost

Medical record must be evolving; Medical record must be evolving; availability of broadbandavailability of broadband

Increasing dimension of data Increasing dimension of data and multiplicity of dataand multiplicity of data

An accessible electronic medical An accessible electronic medical record; record; unique identifier of unique identifier of patients and Health patients and Health ProfessionalsProfessionals; ; Health cardsHealth cards

Increase in lifeIncrease in life--expectancyexpectancy

Ageing of populationAgeing of population

FollowFollow--up of patients during up of patients during lifetimelifetime

The needThe need20052005

Communication: COM(2004) 356 final ‘e-Health – making healthcare better for European citizens: An

action plan for a European e-Health Area’

Communication: COM(2004) 356 final ‘e-Health – making healthcare better for European citizens: An

action plan for a European e-Health Area’

ee--Health action plan: main areas of activityHealth action plan: main areas of activity

• National/regional roadmaps (MS, 2005)

• Common approaches for patient identifier (EC+MS, 2006)

• Interoperability standards for EHR and messaging (EC+MS,2006)

• TMA Bridge, I2Health, Semantic Health, RIDE, Semantic Mining…

• Boosting investments in eHealth (MS, 2007)

• Conformity testing and accreditation (MS 2007)

• Deployment of health information networks (MS, 2004-2008)

• Legal framework, certification of qualifications (EC+MS,2009)

Legal issues in eHealthLegal issues in eHealth•• Collection, Collection, sharing,andsharing,and use se of Healthuse se of Health--related related

information whether by/for citizens, patients, information whether by/for citizens, patients, and various levels of health and various levels of health profession/occupationprofession/occupation

•• Delivery of care to patients by health care Delivery of care to patients by health care professionals using eHealth applicationsprofessionals using eHealth applications

•• Use or Sale of Health Related Products Use or Sale of Health Related Products

•• Use of Health Related Personal InformationUse of Health Related Personal Information

•• Privacy and data protection Privacy and data protection

•• Electronic Signatures Electronic Signatures

Legal issues (continued)Legal issues (continued)•• Delivery of Delivery of eHealthcareeHealthcare, in person or , in person or

electronicallyelectronically

•• Requirements concerning professional rules Requirements concerning professional rules

•• Cross border access to health care in the Cross border access to health care in the context of free movement of persons and context of free movement of persons and servicesservices

•• Protecting the consumer in eCommerce Protecting the consumer in eCommerce

•• Implications for Implications for ePharmaciesePharmacies

•• Medical Devices Medical Devices

•• Product Liability Product Liability

•• Advertising of medicinal products for human Advertising of medicinal products for human useuse

Data security - Legal textsData security - Legal texts•• Directive 95/46/EC of the European Parliament and of Directive 95/46/EC of the European Parliament and of

the Council of the European Union, on the protection of the Council of the European Union, on the protection of individuals with regard to the processing of personal individuals with regard to the processing of personal data and on the free movement of such data; Official data and on the free movement of such data; Official Journal of the European Communities of 23 November Journal of the European Communities of 23 November 1995 No. L.281 p.31 1995 No. L.281 p.31

•• Directive 97/66/EC of the European Parliament and of Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy processing of personal data and the protection of privacy in the telecommunications sector.in the telecommunications sector.

•• Directive 2002/58/EC of the European Parliament and of Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the personal data and the protection of privacy in the electronic communications sector (Directive on privacy electronic communications sector (Directive on privacy and electronic communications)and electronic communications)

•• EC Regulation No 45/2001 of the European Parliament EC Regulation No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of protection of individuals with regard to the processing of personal data by the Community institutions and bodies personal data by the Community institutions and bodies and on the free movement of such data.and on the free movement of such data.

Data security - Legal texts (2)Data security - Legal texts (2)

•• Recommendation 2/2001 on certain minimum Recommendation 2/2001 on certain minimum requirements for collecting personal data onrequirements for collecting personal data on--line in the European Union (5020/01/EN/final line in the European Union (5020/01/EN/final WP43) WP43)

•• Directive 1999/93/EC of the European Directive 1999/93/EC of the European Parliament and of the Council of 13 December Parliament and of the Council of 13 December 1999 on a Community framework for electronic 1999 on a Community framework for electronic signatures OJ L 013 , 19.01.2000 p. 0012 signatures OJ L 013 , 19.01.2000 p. 0012

•• 97/7/EC of 20 May 1997 on the protection of 97/7/EC of 20 May 1997 on the protection of consumers in respect of distance contracts, OJ consumers in respect of distance contracts, OJ L 144, 4.6.1997, p. 19; L 144, 4.6.1997, p. 19;

Other legal textsOther legal texts•• Directive 2001/83/EC of the European Parliament Directive 2001/83/EC of the European Parliament

and of the Council of 2 November 2001 on the and of the Council of 2 November 2001 on the Community code relating to medicinal products for Community code relating to medicinal products for human use.human use.

•• §§§§ 5050--53 of the Commission Guidelines on Vertical 53 of the Commission Guidelines on Vertical Restraints, OJ C 291/1 of 13 October 2000Restraints, OJ C 291/1 of 13 October 2000

•• 93/42/EEC of 14 June 1993 on medical devices, OJ 93/42/EEC of 14 June 1993 on medical devices, OJ L 169, 12.7.1993;.L 169, 12.7.1993;.

•• 85/374/EEC of 25 July 1985 concerning liability for 85/374/EEC of 25 July 1985 concerning liability for defective products, OJ L 210, 7.8.1985, p.29, defective products, OJ L 210, 7.8.1985, p.29,

•• Proposal for a Directive Of The European Proposal for a Directive Of The European Parliament And Of The Council amending Directive Parliament And Of The Council amending Directive 2001/83/EC on the Community code relating to 2001/83/EC on the Community code relating to medicinal products for human use, COM(2001) 404 medicinal products for human use, COM(2001) 404 final.final.

Other legal textsOther legal texts

•• Recommendation 2/2001 Data Protection Recommendation 2/2001 Data Protection Working PartyWorking Party

•• Recommendation of Council of Europe 97(5) Recommendation of Council of Europe 97(5) on the protection of Medical Dataon the protection of Medical Data

•• Communication on High Level Reflection Communication on High Level Reflection Process on Patient Mobility (2004)Process on Patient Mobility (2004)

•• Communication on Healthcare and Care for Communication on Healthcare and Care for the Elderlythe Elderly

•• Communication on Health Insurance Card Communication on Health Insurance Card (2003)(2003)

Other legal textsOther legal texts

•• Communication on Quality criteria for Communication on Quality criteria for Health Related Websites (2002)Health Related Websites (2002)

•• Communication on the Web Accessibility Communication on the Web Accessibility Initiative (2001)Initiative (2001)

•• Report of the High Level Committee on Report of the High Level Committee on Health on Health TelematicsHealth on Health Telematics

•• Opinion of the European Group on Opinion of the European Group on Implantable ICT Devices (2005)Implantable ICT Devices (2005)

•• Opinion of the European Group on Ethical Opinion of the European Group on Ethical Issues of Healthcare in the Information Issues of Healthcare in the Information Society (1999)Society (1999)

Economic and productivity Impact of eHealth

Best practices

Legal aspects of eHealth

i2HEALTHIdentification doctors/patient

Messages/requests

SDOs

RIDESEMANTIC HEALTH

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DiscussionDiscussion

This paper was produced for a meeting organized by Health & Consumer Protection DG and represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumer Protection DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof.